- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06165861
The Effect of Using Virtual Reality Glasses on Surgical Fear and Anxiety
The Effect of the Use of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open Heart Surgery
The purpose of this clinical study is to evaluate the effect of using virtual reality glasses on the surgical fear and anxiety levels of patients undergoing open heart surgery on the morning of surgery. The main hypotheses are:
- The surgical fear level of patients who use virtual reality glasses on the morning of surgery is lower than patients who do not use virtual reality glasses.
- The anxiety level of patients who use virtual reality glasses on the morning of surgery is lower than patients who do not use virtual reality glasses.
Before the surgery, study group patients will be asked to watch videos using virtual reality glasses.
Study Overview
Status
Intervention / Treatment
Detailed Description
The group distribution of the patients was made using the Random Allocation Software (Version 2.0.0) program and the patients were divided into two groups: the study group and the control group.
Patients in the study group were asked to watch videos using virtual reality glasses between the first, second and third evaluation before surgery.
The researcher visited the patients in the cardiovascular surgery ward before the surgery and reported that the patients in the study group would watch video (including nature sounds such as bird sounds, water sounds, etc) with virtual reality glasses. Patients in the control group were informed that the normal service protocol would be applied.
The Surgical Fear Scale was developed to measure the surgical fear levels experienced by patients before surgery. To assess surgical fear, patients are asked to rate their fear level for each question with a number ranging from 0 - 'I am not afraid at all' to 10 -'I am very afraid'. Visual Analog Scale - To evaluate anxiety, patients are asked to mark the anxiety they perceive on a line ranging from 0 -'no anxiety' to 10 -'highest level of anxiety'. The total score of the surgical fear scale is obtained by summing the scores of all scale questions; The lowest score that can be obtained is 0 and the highest score is 80. A lower score indicates that patients experience less surgical fear during their activities. Higher scores indicate a higher level of surgical fear.
To perform the first evaluation in the study group, the researcher went to the patient and evaluated the patient introduction form and surgical fear and anxiety levels. Then, the researcher nurse explained that they were waiting for the operating room team to arrive and gave the patients brief information about the virtual reality glasses. Then, entrances and exits to the room were restricted to ensure that the room was quiet enough to watch videos and away from distracting elements. Patients were then asked to watch the video carefully and focus on the video sounds. Virtual reality glasses were fitted to the patients and videos were started to be watched. The nurse researcher remained in the patient's room until the video ended. At the end of the video, the glasses were taken from the patient and disinfected, and the researcher nurse left the patient room. Then, a second evaluation was made by the service nurse. The third evaluation was made by the researcher nurse when the patients were taken down to the operating room waiting room.
In the control group, the first evaluation was made by the researcher nurse. Then, normal service protocol was applied to the control group patients and a second evaluation was made by the service nurse before going down to the operating room waiting room. The third evaluation was made by the researcher nurse in the operating room waiting room.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Edirne, Turkey, 22030
- Seher Ünver
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the research,
- Will undergo open surgery,
- Will undergo planned surgical intervention,
- Being over 18 years of age,
- No visual impairment,
- No hearing impairment,
- No speech impediment,
- Lack of a psychiatric diagnosis was included.
Exclusion Criteria:
- Having an emergency surgical procedure
- Having a visual impairment
- Having a hearing impairment
- Being under 18 years of age
- Lack of mental health
- Having a speech impediment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental (with VR-G)
The patients in this procedure watched video with using VR-G for approximately 6 minutes at the surgical clinic before going surgery.
|
Watching video with using VR-G before undergoing open heart surgery
|
|
No Intervention: Standard (No VR-G)
The patients took the standart protocol of the surgical clinic and didn't watch video with using VR-G
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical Fear
Time Frame: one day
|
• Surgical fear level [Time Frame: Measurements will start in the surgical ward in the morning of the surgery day before gowning the surgery clothes (such as surgical gown, caps) and will end in the waiting room before transferring to the operating room.] o It will be evaluated using the Surgical Fear Scale. To assess surgical fear, patients are asked to rate their fear level for each question with a number ranging from 0 - "I am not afraid at all" to 10 - "I am very afraid". |
one day
|
|
Surgical Anxiety
Time Frame: one day
|
• Anxiety level [Time Frame: Measurements will start in the surgical ward in the morning of the surgery day before gowning the surgery clothes (such as surgical gown, caps) and will end in the waiting room before transferring to the operating room.] o It will be evaluated using the Visual Analog Scale-Anxiety Scale. To assess anxiety, patients are asked to mark their perceived anxiety level on a horizontal line ranging from 0 - "no anxiety" to 10 - "highest anxiety level". |
one day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seher Ünver, Trakya University
- Principal Investigator: Tuba Erol Akar, Trakya University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-GOBAEK-452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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